General Hospital and Personal Use Devices

Yes

Active implant

General Hospital and Personal Use Devices

Yes

Active implantable medical devices

General Hospital and Personal Use Devices

Yes

Active implantable medical devices

General Hospital and Personal Use Devices

Yes

Active implantable medical devices

General Hospital and Personal Use Devices

Yes

Active implantable medical devices - drug pumps

General Hospital and Personal Use Devices

Yes

Active implantable medical devices - drug pumps

General Hospital and Personal Use Devices

Yes

Active implantable medical devices - drug pumps

General Hospital and Personal Use Devices

Yes

Active implantable medical devices - drug pumps

General Hospital and Personal Use Devices

Yes

Active implantable medical devices

General Hospital and Personal Use Devices

Yes

Active implantable medical devices

General Hospital and Personal Use Devices

Yes

Implant

General Hospital and Personal Use Devices

Yes

Non-active implants

General Hospital and Personal Use Devices

Yes

Active implantable medical devices - drug pumps

General Hospital and Personal Use Devices

Yes

Active implantable medical devices

General Hospital and Personal Use Devices

Yes

Active implantable medical devices

914663, 914663D, 924196, 927904, 973169, 994958, 1000904, 1000905, 1003264, 1017119, 1018949, 1023552, 1033976, 1037228, 1037879.

General Hospital and Personal Use Devices

Unclassified

Yes

Product shipped to 56 medical facilities throughout the U.S.

Vaxcel Plastic Low Profile Port (non-valved) chest port, with 6Fr Polyurethane Catheter, Catalog 45-333, Material #M001453330. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

791550, 915867, 1010168, 1017745, 1022134, 1022488, 1024234, 1038298, 791550D

General Hospital and Personal Use Devices

Unclassified

Yes

Product shipped to 56 medical facilities throughout the U.S.

Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Silicone Catheter, Catalog #45-336, Material #M001453360. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

791549, 915868, 919482, 922594, 923705, 1000906, 1001279, 1003265, 1022911, 1034615, 922594D, 923705D

General Hospital and Personal Use Devices

Unclassified

Yes

Product shipped to 56 medical facilities throughout the U.S.

Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Polyurethane Catheter, Catalog # 45-338, Material #M001453380. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

Cat. No. 45-233, including all lots as follows: 910022, 910022D, 923899, 973167, 974706

General Hospital and Personal Use Devices

Unclassified

Yes

1215 units shipped to 123 hospitals throughout the U.S. 2 units shipped to Boston Scientific in South Africa where 1 unit had been used as a demo (non-human use) and 1 units is in BSC control

Vaxcel Low Profile Port with PASV Valve and 6F Polyurethane Catheter. CATALOG NO. 45-233. Ref. # M001452330. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Place, Natick, MA 01760-1537. Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

Cat. No. 45-236, including all lots as follows: 791486, 906776, 916194, 917025

General Hospital and Personal Use Devices

Unclassified

Yes

1215 units shipped to 123 hospitals throughout the U.S. 2 units shipped to Boston Scientific in South Africa where 1 unit had been used as a demo (non-human use) and 1 units is in BSC control

Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. CATALOG NO. 45-236, Ref. # M001452360. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Place, Natick, MA 01760-1537. Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

Cat. No. 45-238 including all lots as follows: 791484, 791485, 906777, 916195, 916196, 916197, 917026, 918870, 919481, 920550, 921765, 924851D

General Hospital and Personal Use Devices

Unclassified

Yes

1215 units shipped to 123 hospitals throughout the U.S. 2 units shipped to Boston Scientific in South Africa where 1 unit had been used as a demo (non-human use) and 1 units is in BSC control

Vaxcel Low Profile Port with PASV valve and 8F Polyurethane Catheter. CATALOG NO. 45-238, Ref. # M001452380. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Place, Natick, MA 01760-1537. Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

Lot numbers: 14B114CT, 14E011CT, and 14E366CT

General Hospital and Personal Use Devices

3

Yes

Worldwide Distribution-US (nationwide) and the countries of Canada, France, Germany, and Switzerland.

CODMAN 3000 Series Refill Set- Huber needles. || Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump || CATALOG NO. : AP-07014 || Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL Calibrated Syringe Barrel, Tubing Set and Stopcock for pump refills. || .

Serial Number NGV526743H

General Hospital and Personal Use Devices

3

Yes

IL

SynchroMed II implantable drug infusion pump, Model 8637-40,

All

General Hospital and Personal Use Devices

3

Yes

Nationwide Distribution

PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling of the device plus the following Prometra II pump labeling is also being revised: Intrathecal Catheter IFU, REF 11823, PL-22790-02; Catheter Revision Kit IFU, REF 11 830, PL-21798-02; Refill Kit IFU, REF 11825, PL-21794-00; Prometra II Patient Implant Card (Permanent) PL-32300-01; Prometra II Patient Implant Card (Temporary): PL-32375-01; Prometra II Patient Guide: PL-31912-01. || The Prometra Programmable Infusion Pump System is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (sodium chloride injection, USP).

N558983006

General Hospital and Personal Use Devices

3

Yes

Internationally to Japan.

Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.